Regulatory Open Forum

Short of institutionalization, incarceration or interment (anyone want to start a betting pool?), 2020 will be the year that the Regulatory Watchcat finally comes into its own.  This little hobby will probably get its own website, although that's not a burning priority for me, and I will start to actively pursue some projects instead of mostly reacting in horror.

I have no lack of projects to choose from, so I thought I might post a list in some forums and see if anyone had any opinions regarding which of these might be of particular interest to them:

All of these projects are time-intensive and I have several other projects that are already priorities, including my De novo watch, so no one should be holding their breath that I will complete any of these projects next year.   At best, I think I will get a decent start on at least two of them.

Short of institutionalization, incarceration or interment (anyone want to start a betting pool?), 2020 will be the year that the Regulatory Watchcat finally comes into its own.  This little hobby will probably get its own website, although that's not a burning priority for me, and I will start to actively pursue some projects instead of mostly reacting in horror.

I have no lack of projects to choose from, so I thought I might post a list in some forums and see if anyone had any opinions regarding which of these might be of particular interest to them:

All of these projects are time-intensive and I have several other projects that are already priorities, including my De novo watch, so no one should be holding their breath that I will complete any of these projects next year.   At best, I think I will get a decent start on at least two of them.

UPDATED 12/2020:

Everyone has their "This was the year I was going to…" stories.  This one is mine. I had to chuckle when I re-read the first sentence of my post last February.  Apparently I overlooked a fourth option, oops.

The last sentence made me laugh darkly, as I ended up mostly reacting in horror to, among other things, pretty much everything going on at FDA this year.

That said, contrary to how it must have seemed to those of you who are Connected with or Following me on LinkedIn, I haven't actually spent the entire pandemic ranting there.  I was concurrently engaged in a long slow chug through the De novo biocompatibility data.  Through, and through, and through again.  First an endless number of passes to identify the different types of information available and figure out how to organize it in some useful way.  Then over and over again, each time pulling some information and being stumped by other information.  Surprisingly, not all of the summaries are a shining tribute to superb writing skills, heh.

After all that…well, it's a start.

And a stop, at least for now.  I am not at all ready to tackle the 510(k) and PMA biocompatibility sections for comparison to the De novo.  And, on the whole, I think I've had enough of the De novo for a while.  Sometime in the first two quarters of next year, I might tackle software, which I'm expecting to be pretty straightforward (heh), but if it isn't, I'll put it off for another day. Or year.

For now, I'm planning to write up the biocompatibility information data I was able to compile this year, as the fourth installment of my neverending De novo analysis.  I am aiming to post it to the forum before my RAPS membership expires on Saturday.

Short of institutionalization, incarceration or interment (anyone want to start a betting pool?), 2020 will be the year that the Regulatory Watchcat finally comes into its own.  This little hobby will probably get its own website, although that's not a burning priority for me, and I will start to actively pursue some projects instead of mostly reacting in horror.

I have no lack of projects to choose from, so I thought I might post a list in some forums and see if anyone had any opinions regarding which of these might be of particular interest to them:

All of these projects are time-intensive and I have several other projects that are already priorities, including my De novo watch, so no one should be holding their breath that I will complete any of these projects next year.   At best, I think I will get a decent start on at least two of them.

Short of institutionalization, incarceration or interment (anyone want to start a betting pool?), 2020 will be the year that the Regulatory Watchcat finally comes into its own.  This little hobby will probably get its own website, although that's not a burning priority for me, and I will start to actively pursue some projects instead of mostly reacting in horror.

I have no lack of projects to choose from, so I thought I might post a list in some forums and see if anyone had any opinions regarding which of these might be of particular interest to them:

1. Estimate the average cost of developing a 510(k) device from prototype to product.

2. Determine whether CDRH can connect the dots between the devices it reviews premarket, the data that are submitted to support them, and the devices that are marketed post-whatever. Then, if it looks like it can, whether it does.

3. Estimate the percentage of medical device startups that "fail." (Has anyone here ever seen a primary source for any of the numbers that get bandied about on the internet?)

4. Evaluate the quality of CDRH decision summaries from a perspective of meaningful transparency.

All of these projects are time-intensive and I have several other projects that are already priorities, including my De novo watch, so no one should be holding their breath that I will complete any of these projects next year.   At best, I think I will get a decent start on at least two of them.

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Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com
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